Hard shell carry case for the LIFEPAK 500 AED.
This recall has been terminated (originally issued October 4, 2005).
- Recall Initiated
- July 12, 2005
- Posted
- October 4, 2005
- Terminated
- June 26, 2006
- Recall Number
- Z-0004-06
- Quantity
- 4608 cases
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
Distribution
Cases were distributed nationwide and internationally.
Lot / Code Info
Cases do not contain serial numbers or lot numbers. Catalog number 3005384-000 through 002
Root Cause
Process control
Action Taken
On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.